Search results for biologicals

Roundtable on registries: practical considerations for registries – making them work, London, UK, 26 January 2017

Author byline as per print journal: Stuart Bloom, DM, FRCP; Keith Bodger, MBChB(Honours), MD, FRCP; Fraser Cummings, BMSc(Hons), MBChB, MRCP(UK), DPhil, FRCP; Professor Sarah Garner, BPharm, PhD; Professor Kimme Hyrich, MD, PhD, FRCPC; Clare Jacklin; Professor John G Williams, CBE, FRCP Introduction: Registries collect clinical data to evaluate specified outcomes for a population defined by a particular disease, condition […]

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Roundtable on biosimilars: pharmacovigilance, traceability, immunogenicity, 15 November 2016, Madrid, Spain

Author byline as per print journal: Professor Francisco José de Abajo, MD, MPH, PhD; Professor Joan Albanell, MD; Olga Delgado Sanchez, PharmD; Kevin Klein, MSc; José Vicente Moreno-Muelas, MD; Sol Ruiz, PhD; Professor Maria Jesús Sanz Ferrando, PhD; Robin Thorpe, PhD, FRCPath; Professor Francisco Zaragozá, PhD Introduction: Biosimilars can offer a lower-cost alternative to current biological therapies and could […]

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Pharmacovigilance of biosimilars and other biologicals within the hospital: current practices and future challenges

Author byline as per print journal: Barbara OM Claus, PharmD, PhD; Tiene Bauters, PharmD, PhD; Annemie Somers, PharmD, PhD Abstract: In the coming decade, many patents for biological pharmaceuticals will expire. Consequently, the market for biosimilars has the potential to grow rapidly. For safety reasons, the more extensive use of a greater variety of biologicals increases […]

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Naming and labelling of biologicals – the perspective of hospital and retail pharmacists

Author byline as per print journal: Professor Philip J Schneider, MS, FASHP; Michael S Reilly, Esq Introduction: To date, the US Food and Drug Administration (FDA) has offered only draft guidance on the naming of biosimilar medicines. The Alliance for Safe Biologic Medicines (ASBM) has asked pharmacists for their views on the labelling and naming of […]

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Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of healthcare funding is spent on biological drugs (including growth factors and monoclonal antibodies) which are commonly used in the setting of haematology and blood and […]

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Demonstrating interchangeability and biosimilarity for US biosimilars

Abstract: The US Food and Drug Administration (FDA) outlines its approach to biosimilarity and interchangeability at the 2016 Generic Pharmaceutical Association Biosimilars Council Conference. Topics covered include the FDA definition of biosimilarity, its step-wise approach to the approval process and factors/issues that should be considered when providing scientific justification for extrapolation. Submitted: 22 September 2016; […]

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US FDA proposals for naming of biologicals and labelling of biosimilars

Abstract: There is considerable concern and debate over the naming of biologicals and labelling of biosimilars. To ensure that patients receive the safest and most effective treatment, it is paramount that clinicians, prescribers and patients themselves have the relevant information regarding drug treatment. In response to concerns over how biologicals and biosimilars should be named […]

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Ever-changing landscape of biosimilars in Canada; findings and implications from a global perspective

Author byline as per print journal: Brian Godman1,2,3, BSc, PhD; Eleonora Allocati4, BSc, MSc; Evelien Moorkens5, BSc, MSc Abstract: Siu et al. comprehensively assessed the rapidly changing regulation and reimbursement environment for biologicals and biosimilars in Canada and the resultant implications. The current situation in Canada is compared with similar initiatives across different countries to […]

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First MENA educational workshop on regulation and approval of similar biotherapeutic products/biosimilars, Dubai, United Arab Emirates, 1 September 2015

Introduction: Similar biotherapeutic products (SBPs or biosimilars) include a rapidly expanding number of therapeutic products worldwide. However, agreement about the best practices for their regulation are lacking in many countries including in the Middle East and North Africa (MENA). Methods: The first MENA educational workshop on SBPs was held in Dubai, UAE on 1 September […]

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Update on US state legislation on biosimilars substitution

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update of the current situation. Submitted: 21 April 2015; Revised: 8 May 2015; Accepted: 11 May 2015; Published online first: 25 May 2015 The Biologics Price […]

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Biosimilars: patient and physician acceptability is the fifth hurdle to market competition

Abstract: Biosimilar products confront novel market authorization and post-marketing use hurdles. Existing evidence is insufficient to fully address physician and payer acceptability thresholds. Submitted: 4 March 2015; Revised: 5 March 2015; Accepted: 9 March 2015; Published online first: 20 March 2015 In this issue of GaBI Journal, Sandorff et al. [1] investigate payer and physician […]

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First Latin American educational workshop on similar biotherapeutic products, Mexico City, Mexico, 20 January 2015

Introduction: Similar Biotherapeutic Products (SBPs or biosimilars) comprise a rapidly expanding area of therapeutics worldwide. However, best practices for their regulation are lacking in many Latin American countries. Methods: The first in a series of educational workshops on SBPs in Latin America was held in Mexico City on 20 January 2015. Didactic presentations covered the […]

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